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# Draft Guide on Pediatric Disease Priority Vouchers
- URL: https://www.fdaweb.com/draft-guide-on-pediatric-disease-priority-vouchers/
- Published: 2019-07-29T12:00:00.000Z
- Updated: 2026-09-15T01:40:35.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144638

FDA has issued a revised draft guidance, [Rare Pediatric Disease Priority Review Vouchers](http://email.prnewswire.com/wf/click?upn=zySGXW1QLHU8t7wSbPI8iADmwAaKTbie2jeFmcdktodnu-2BcmO-2BNUa37asNwbbRarSKwqzjPKf-2BTwzu4nCM4RsvfItzsBUpP7-2BNHKpqqws7hLPfe1gMQiOil6gDostV5SB28dH6bt6NJlwQhjWH4SQ2Bo-2FiAJ3xjgyYXyvBFEXNx9OMrXLd6EhdS3Cm018qYIk9YMER9WqzBTp2zxiaqi32NY9BY7pUA6SnJqtvlgJdLDV8afUWWCafJe22JWFbL-2F9fMRbkAaeQSDR-2FNw2R-2BM4wl2gyVUzL137bWhx7PsiWiEaSM6pzqahL1woAaF-2Bbox-2F27W36j2250HaKOXI01cBDzSTxAKmDt70ySXBKeVSsY-2FKTkZPkCtY0-2Ba8OEEjsl4r6exdgqSgrAQQQ2qbwfELw-3D-3D%5FnE9rxSXA5G4kxsTVkgv43tTJnmhvULg8vMtvbdZHwXEle6c6tqdvw12Z3skft0RuKMc0EB09E3tUgbfrLBzKhQVKBl1ss7jS3fxqTgekAhUhUH14ihR-2BTYvx6TOgfPCDBsfZcJWbseUNl0yV-2Bw8EOMCEmPjkE-2BxKfQbCi4xekJZkatC0URMjitBkJhxMd8SZnMM8R6YR8awAcrkjDbaQQhaFblesn1awcfGm6NiVU1RMiODAgrltToe1s-2BkYexJ61Kvu58hgH12O1-2Fxd7uEFgf-2FY2jIlk89Hos0KYVJOzhn-2BQkAUl06wa0Ixcn4oe4zkefBq50mU3gqJnx6q4BOv3JS6QRXH4-2B6bTC99ziRUA-2FE-3D&ref=fdaweb.com). The document incorporates public comments received on an initial draft and provides FDA’s thinking on the Advancing Hope Act of 2016 provisions, which updated the definition of a rare pediatric~~s~~ disease as one that is both rare and serious or life-threatening with manifestations primarily affecting individuals from age zero to 18\. Among the changes from the initial draft are discussions on the rare pediatric disease priority review voucher eligibility requirements, the rare pediatric disease designation process and examples to illustrate the agency's current thinking on these review determinations.